An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:September 30, 2015
End Date:November 20, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

In this study, all patients must have already completed first-line chemotherapy to treat
extensive-stage disease small cell lung cancer. The purpose of this study is to show that
nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall
survival when administered as consolidation treatment in patients that are stable or
responding after chemotherapy. Patients receiving treatment will be compared with patients
taking placebo.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects with histologically or cytologically confirmed extensive stage disease SCLC

- Ongoing response of stable disease or better following 4 cycles of platinum-based
first line chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Subjects with symptomatic Central Nervous System (CNS) metastases

- Subjects receiving consolidative chest radiation

- Subjects with active, known, or suspected autoimmune disease are excluded

- All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1
or baseline
We found this trial at
29
sites
Sutter Cancer Center
Sacramento, California 95816
Phone: 916-445-6931
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Beth Israel Deaconess Medical Center
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Duke University
Durham, North Carolina 27710
(919) 684-8111
Phone: 919-681-4768
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Providence Portland Medical Center
4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-2699
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Lehigh Valley Health Network
Allentown, Pennsylvania 18105
Phone: 610-402-1642
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Winship Cancer Institute
Atlanta, Georgia 30322
Phone: 404-778-4582
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Atlanta, GA
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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21231
Phone: 443-287-9377
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Baltimore, MD
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Local Institution
Berazategui, Buenos Aires
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Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-8795
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Oncology Hematology Care
5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-366-6387
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas 66205
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Fairway, KS
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Sanford Health
Fargo, North Dakota 58122
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Florida Cancer Specialists S.
Fort Myers, Florida 33916
Phone: 941-766-7222
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Franciscan St. Francis Health, Site
Indianapolis, Indiana 46237
Phone: 317-782-7060
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Indianapolis, IN
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Cancer Specialists Of North Fl
Jacksonville, Florida 32256
Phone: 904-825-4500
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Jacksonville, FL
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Baptist Health Lexington
Lexington, Kentucky 40503
Phone: 859-260-6406
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Yale University
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4203
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Virginia Cancer Institute
Richmond, Virginia 23235
Phone: 804-288-7159
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Richmond, VA
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-4140
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Florida Cancer Specialists
Saint Petersburg, Florida 33705
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Huntsman Cancer Institute
Salt Lake City, Utah 84112
Phone: 801-585-7844
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Donald Guthrie Foundation
Sayre, Pennsylvania 18840
Phone: 570-887-4882
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Sayre, PA
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Sanford Health
Sioux Falls, South Dakota 57104
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Cancer Center of Kansas
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Phone: 316-268-8566
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Novant Health Oncology Specialists
Winston-Salem, North Carolina 27103
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